1
Setting the Stage

Less than two decades ago, genetically engineered organisms (GEOs) were the subject of much scientific study, but not part of everyday life. By 2006—eleven years after the first commercial introduction of corn plants engineered to produce their own insecticide (the delta endo-toxin gene of the bacterium Bacillus thuringiensis, or Bt)—more than 123 million acres of land in the United States were planted with genetically engineered crops. Today, 89 percent of all soybeans, 83 percent of cotton, and 61 percent of corn grown in the United States are the products of genetic engineering (Fernandez-Cornejo and Caswell, 2006). Other GE plants, trees, microbes, insects, and fish are on the horizon.

A key question related to GE crops has been their potential and actual effects on the environment, and numerous studies have been conducted to assess the risks and examine the outcomes of transgenic crops. Those studies have generally informed and strengthened the regulatory oversight of GEOs, but questions still linger in the scientific community about whether GE crops have been evaluated in a broad, long-term ecological context that might expose more subtle effects over time. Those questions also apply to the next generation of GEOs that are in development or poised for field study. Given the diversity of taxa involved and novel traits contemplated, ecologists wonder how the environmental effects of the new GEOs might be manifested, if at all, and how such effects can be detected.

With those concerns in mind, research leaders at the U.S. Geological Survey’s (USGS) Biological Resources Division (BRD) asked the National

The National Academies of Sciences, Engineering, and Medicine 500 Fifth St. N.W. | Washington, D.C. 20001

Citation Manager

Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 1
1
Setting the Stage
L
ess than two decades ago, genetically engineered organisms (GEOs)
were the subject of much scientific study, but not part of everyday
life. By 2006—eleven years after the first commercial introduction of
corn plants engineered to produce their own insecticide (the delta endo-
toxin gene of the bacterium Bacillus thuringiensis, or Bt)—more than 123
million acres of land in the United States were planted with genetically
engineered crops. Today, 89 percent of all soybeans, 83 percent of cotton,
and 61 percent of corn grown in the United States are the products of
genetic engineering (Fernandez-Cornejo and Caswell, 2006). Other GE
plants, trees, microbes, insects, and fish are on the horizon.
A key question related to GE crops has been their potential and actual
effects on the environment, and numerous studies have been conducted
to assess the risks and examine the outcomes of transgenic crops. Those
studies have generally informed and strengthened the regulatory over-
sight of GEOs, but questions still linger in the scientific community about
whether GE crops have been evaluated in a broad, long-term ecological
context that might expose more subtle effects over time. Those questions
also apply to the next generation of GEOs that are in development or
poised for field study. Given the diversity of taxa involved and novel
traits contemplated, ecologists wonder how the environmental effects of
the new GEOs might be manifested, if at all, and how such effects can be
detected.
With those concerns in mind, research leaders at the U.S. Geological
Survey’s (USGS) Biological Resources Division (BRD) asked the National

OCR for page 1
GENETICALLY ENGINEERED ORGANISMS, WILDLIFE, AND HABITAT
Research Council (NRC) to organize a workshop of developers of GEOs,
ecologists, land managers, and others to discuss GEOs in the context of
ecological research. Rather than assessing the potential environmental
risk of any particular transgenic organism, the USGS was interested in
identifying different research approaches that could be useful in anticipat-
ing, understanding, and detecting effects of GEOs on wildlife and natural
habitats. This report is a summary of the discussions that emerged from
that workshop, held in Irvine, California, on November 6 and 7, 2007.
POTENTIAL TRAITS AND EFFECTS
Almost all currently produced GE (also known as genetically modi-
fied, or GM) crops contain genes for herbicide tolerance, Bt production,
or both. But beyond these crops, research and testing are under way in
a large variety of plants (including trees), microorganisms, and animals
(including insects and aquatic species) to introduce a much broader range
of traits with potential benefits for farmers, consumers, and other users
of GE products (see Box 1-1). These traits include resistance to disease,
drought tolerance, greater nutritional content, production of pharmaceu-
tical products, and altered starch structure for industrial uses such as in
biofuels. Transgenic plants and animals engineered to produce vaccines
and human proteins already have been created and some are being field-
tested. The potential to genetically engineer insect and aquatic species for
the purpose of developing effective biocontrol agents is another subject
under active investigation—for example, a GEO that can help control a
non-native aquatic species—yet at much earlier stages of development.
One of the primary reasons that most GEOs have not been commer-
cialized or even extensively field-tested is the continued uncertainty about
their risks to the environment, both managed and wild. In a number of
reports published by the National Research Council (NRC 2000, 2001,
2002a, 2002b, 2004), potential environmental impacts identified included
the following:
• Direct and indirect effects on plant and animal species coexisting
with transgenic plants and animals.
• Interbreeding or hybridization with and horizontal gene transfer
to species related to the GEO, creating novel organisms in the ecosystem
that are potential pests, competitors, or that depress the fitness of wild
relatives.
• Spread of biologically active agents, such as viruses, to non-
transgenic species, and the emergence of recombinant viruses.
• Spread of novel proteins produced by the GEO to the air, water, or
soil in which plants and animals live.

OCR for page 1
SETTING THE STAGE
BOX 1-1
Genetically Engineered Traits in Experimental Development
Crops
Drought and salt tolerance
Nitrogen and water use efficiency
Nutritional amendments—oils and proteins/amino acids
Herbicide tolerance mechanisms (novel)
Disease and pest resistance (plant insecticides, lectins)
Biofuels (cellulosic digestion; carbohydrate storage)
Senescence/ripening/phenology
Industrial uses—starches/oils/fibers
Microorganisms
Fungi and bacteria with enhanced virulence characteristics for insect control
Fermentation of substrates, antimicrobial producers, probiotics for “active”
foods, attenuated vaccines (bacterial and viral)
Phage for plant disease control
Biofuels related (cellulose, lignin degradation)
Nitrogen fixation in non-traditional plants
Insect symbionts for paratransgenic control
Animals
Growth promotion—(growth hormone) cattle, fish, shellfish
Medically valuable proteins in milk
Disease resistance (antimicrobial peptides, viral resistance, BSE) in cattle,
swine, poultry, fish, bivalves
Insects—disease resistance and pharmaceutical production
Vector disruption—(Malaria, Dengue)
Product quality—(silk, high value proteins)
Viral resistance in honey bees
Source: Chris Wozniak (workshop presentation)
• Indirect effects on wildlife and habitat ecosystems because of
changes in the management of agriculture, forestry, and fisheries related
to GEOs.
The ability to understand the potential for these effects to occur on
a large scale over a long time period—particularly in the cases of trees,
aquatic species, and microbes—is confounded by regulatory requirements
for the confinement of an experimental GEO during testing. That poses
a difficult challenge for GEO developers and evaluators. There is little
known about the likelihood or magnitude of impact of GEOs, so they can-
not be released into the environment for research purposes. Yet, a better

OCR for page 1
GENETICALLY ENGINEERED ORGANISMS, WILDLIFE, AND HABITAT
understanding of the potential and actual effects of GEOs relative to other
influences on the environment (for example climate change, invasive spe-
cies, or land use changes) requires approaches that take into account both
the specific characteristics of GEOs and the character and resilience of the
environment, as well as the extent of the interaction between the GEO and
the environment. That understanding could be best achieved by observa-
tion in an actual environmental setting.
How will this impasse be overcome? In her welcoming presentation,
Anne Kapuscinski described the role of ecological research in informing
the decision-making process of risk assessment. That role includes gather-
ing information, identifying the appropriate parameters for consideration,
and analysis of complex systems. Because interest in the development
and implementation of GEOs with a variety of traits is likely to increase
in the future, concerns about potential environmental hazards need to be
translated into specific research questions that produce data to inform
those who evaluate and manage the risks of GEOs. That does not mean
that ecological research is necessarily narrow; it may be focused on how
natural systems operate more generally to elucidate more general prin-
ciples. But that information is also relevant to work of risk assessors in the
federal agencies with regulatory authority and the agencies tasked with
overseeing the integrity of publicly owned land.
FEDERAL RESPONSIBILITIES
In 1986, the Coordinated Framework for the Regulation of Biotechnol-
ogy defined roles for federal agencies in regulating the products of bio-
technology. The framework focused on products being developed at the
time, mainly transgenic microbes and plants, and did not focus on taxa of
other GEOs or on the effects of GEOs on wildlife and their habitats.
In order to address uncertainties about these issues and other emerg-
ing products of biotechnology, in May 2000, the White House Office of
Science and Technology Policy and the Council for Environmental Quality
undertook a review of the relevant agencies and statutes for regulating
biotechnology products. This review, completed in January 2001, along
with a number of federal and state laws, covers oversight of GEOs today
(CEQ/OSTP 2001).
Under this policy, the U.S. Department of Agriculture (USDA) (and
particularly its Animal and Plant Health Inspection Service [APHIS]),
the U.S. Environmental Protection Agency (EPA), and Food and Drug
Administration (FDA) share responsibility for regulating GEOs. USDA
has the authority to provide permits for testing of GE plants and some
animals, for regulating their production, including an assessment of envi-
ronmental risks. EPA has authority over plants and microorganisms that

OCR for page 1
SETTING THE STAGE
produce pesticides (such as the Bt crops). FDA must approve the market-
ing of GEOs as food, and under the National Environmental Protection
Act, FDA may also consider the environmental effects of production of
transgenic animals.
Among many federally funded research programs on GEOs, the USDA
Biotechnology Risk Assessment Grants (BRAG) Program was established
in 1992 by an act of Congress. Through the Farm Security and Rural
Investment Act of 2002, the BRAG Program funds “research designed
to identify and develop appropriate management practices to minimize
physical and biological risks associated with genetically engineered ani-
mals, plants and microorganisms.” According to Chris Wozniak, who
presented information about BRAG, approximately 140 projects have
been funded (maximum award of $400,000) since 1992, with an emphasis
on studies that “will provide information useful to regulators for mak-
ing science-based decisions in their assessments of genetically modified
organisms” (USDA, 2008).
Other agencies also become involved as GEOs interact—or have the
potential to interact—with the environment. For example, the Department
of Interior’s Fish and Wildlife Service and Bureau of Land Management
(BLM) and the Department of Commerce’s National Marine Fisheries Ser-
vice may assert the authority of the Endangered Species Act, the National
Invasive Species Act of 1996, and other federal legislation. In addition,
most oversight authority for wildlife and fisheries resources rests with
the states, six of which, as of this publication, have issued regulations
prohibiting releases of aquatic or marine GEOs.
WORKSHOP PURPOSE AND ORGANIZATION
The Department of Interior’s USGS does not have regulatory or over-
sight authority over GEOs, but its mission to provide reliable scientific
information to other agencies and to the public gives it an important role
in strengthening the information base about the effect of GEOs on the
environment. The USGS BRD, one of the agency’s four broad topical dis-
ciplines, “works with others to provide the scientific understanding and
technologies needed to support sound management and conservation of
our Nation’s biological resources” (USGS, 2008).
Bob Szaro (USGS) explained that the USGS is a scientific advisor to
several federal agencies with stewardship responsibility for public lands,
including the BLM, the National Park Service, and other agencies. In that
capacity, the BRD requested that the NRC organize a workshop to fur-
ther approaches to understanding the effects of GEOs on terrestrial and
aquatic ecosystems. The workshop’s expected outcome was to identify
fundamental information needs and prioritize research directions. It also

OCR for page 1
GENETICALLY ENGINEERED ORGANISMS, WILDLIFE, AND HABITAT
was designed to identify existing research and monitoring that could pro-
vide a platform for GEO-related research on the ecological effects of GEOs
and lead to new partnerships, projects and resources for these complex
and critical areas of inquiry. BRD asked the workshop planning commit-
tee and workshop participants to focus on approved GEOs already in the
environment and those that may reasonably be expected to be developed
within the next five to ten years (see Box 1-2).
In early 2007, a committee of nine scientists was appointed to plan
the workshop. An in-person meeting and numerous conference calls cul-
minated in the two-day Workshop on Genetically Engineered Organisms,
Wildlife, and Habitat at the Arnold and Mabel Beckman Center in Irvine,
California, November 6 and 7, 2007.
The workshop involved federal, university, and other scientists who
conduct research on GE plants, trees, microbes, insects, and fish, as well
as those who focus on the ecosystems that these GEOs might affect.
Representatives of federal agencies involved in regulatory oversight also
participated. The workshop began with some basic information on GEOs,
including an overview of what GEOs exist and what new GEOs are
planned for development in the next five to ten years, and an overview
of the USGS and specifically, the BRD. The information from the introduc-
tory session has been summarized in this chapter.
The workshop continued with presentations on the status of current
research—and, as importantly, on current research gaps—on the effects
of GEOs on terrestrial and aquatic wildlife and habitats. These presenta-
BOX 1-2
Statement of Task
An NRC committee will organize a public workshop of experts, resource man-
agers, and others to identify research activities with the greatest potential to pro-
vide scientific information and data that would improve the ability to assess the
ecological risks and impacts of genetically engineered organisms (GEOs) on ter-
restrial and aquatic wildlife and their habitats in the United States. The workshop
will be organized around key concerns related to the interaction of GEOs with
natural environments and consider the specific types of data needed to evaluate
the risk and impact of GEOs on wildlife and their habitat. In addition to identifying
various scientific approaches to obtaining the necessary data, the workshop will
consider whether and how research needs and approaches for evaluating the risk
and impact of GEOs might complement or build on existing research, surveillance,
and monitoring activities in natural areas. A rapporteur will produce an individually-
authored summary of the workshop.

OCR for page 1
SETTING THE STAGE
tions describing current GEO research were organized by taxa, and were
followed by presentations of potential models which could be used to
study GEOs in the environment. Models presented included invasion
ecology, gene flow, and landscape analysis. These presentations helped
inform the breakout discussions and are summarized in Chapter 2 of this
publication.
The plenary presentations and group discussions did not evaluate
the potential risks of GEOs to the environment or the methodologies for
risk assessment. Instead, discussions within the workshop explored how
GEOs could be studied in the context of natural habitats, what some of the
interactions of GEOs with the environment could be, and what research
questions related to environmental interactions would be important to
consider.
In keeping with the statement of task, the heart of the workshop, as
reported in Chapter 3, focused on breakout sessions to identify research
that could be pursued to better understand GEO-ecosystem interactions.
For the breakouts, participants were divided by ecosystem type: two
groups focused on the agriculture/wildland interface, and one each on
the silviculture/wild forest and on the aquaculture/aquatic habitat inter-
face. These groups identified several broad research priorities for “their”
interface, and then reported back in a plenary session for clarification and
discussion. In a second round of breakouts, participants began to develop
research proposals to address the research topics identified. Although
time constraints made detailed proposals impossible, they serve as a start-
ing point for funding and regulatory agencies, particularly as they seek
to fill information gaps in assessments of the risks of GEOs to wildlife
and habitat. As additional input to USGS and others, the final thoughts
on the workshop by committee members and participants are contained
in Chapter 4.
The agenda for the workshop can be found in Appendix A. Short
biographies of the committee members and workshop participants are
contained in Appendix B. The role of the workshop planning committee
was to develop the agenda for the meeting, invite speakers, and recruit
participants. This report, which is meant to present a factual summary of
what occurred at the workshop, was prepared by a rapporteur, indepen-
dent of the committee, and was reviewed for accuracy by several partici-
pants who were in attendance.